Validation Compliance Annual

1995

Inbunden, Engelska, 1995

Av International Validation Forum, USA) Validation Forum, International (International Validation Forum, Boothwyn, Pennsylvania

6 929 kr

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"Offers an overview of validation and the current regulatory climate and provides a compendium of the regulations, guidance documents, issues, compliance tools, terminology, and literature involved in computer systems validation. Thoroughly examines regulations issued by the U.S. Food and Drug Administration, the U.S. Environmental Protection Agency, and the European Union. Furnishes case studies of real-world situations."

Produktinformation

Utgivningsdatum1995-02-17
Mått178 x 254 x undefined mm
Vikt2 210 g
FormatInbunden
SpråkEngelska
Antal sidor1 110
FörlagTaylor & Francis Inc
ISBN9780824794590

Tillhör följande kategorier

Overview - behind validation, the regulatory world; government regulation - FDA regulation, EPA regulations, European union regulations; situational review - situational review by industry, situational review in the USA, international situational review; tools for validation - validation checklist, the use of an SDLC in system validation, data integrity and security, documentation - the SOP, electronic signatures, drug inspections, biologics inspections, medical device inspections, hazard analysis; field findings - FDA adverse findings, case study experience - sixteen theses; future developments - future developments. Appendices: glossary; validation bibliography.